The U.S. Food and Drug Administration (FDA), though it has improved a drug labeling regulation through revisions announced January 18, continues to ignore the fact that its rule will not guarantee patients the most accurate, up-to-date information about their medications, Public Citizen said today.
Further, in an end-run around Congress, the FDA has added to the rule a preamble designed to preempt lawsuits filed by patients under state law, potentially leaving victims of FDA-approved drugs with no remedy for any harm caused by the approved drug.
Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group, said revisions in the final version of the rule released today will simplify and prioritize the labeling information that doctors receive. But the vast majority of patients will not get that information unless they specifically request it. Instead, they commonly receive patient information leaflets (PILs) that are commercially produced but whose content is not scrutinized by the FDA.
"The FDA’s own study has shown that the content of unregulated leaflets gets a failing grade (average 50 out of 100) in conveying the most important information to patients," Wolfe said. The agency has the authority to require agency-approved ‘medication guides’ for each new prescription and refill but has done so for only about 75 drugs.
"It is time to end the double standard where doctors and other health professionals are informed by FDA-approved labeling, but patients are treated like second-class citizens, receiving whatever the out-of-control purveyors of patient information leaflets choose to dispense," Wolfe said. "This is a dangerous situation, made worse by the FDA’s poor record of approving harmful drugs based on limited, and even fraudulent, clinical trials performed by the drug companies."
In a further blow to consumers, the final rule now contains a preamble aimed at preempting the rights of patients to sue drug manufacturers if a drug is approved by the FDA. The Bush administration has previously failed to persuade Congress and, with a few exceptions, the courts (where it has filed amicus briefs) to shield drug makers from liability.
"The new tactic of writing preemption language into federal regulation notices is an attempt to bypass Congress and override consumer protection liability laws," said Public Citizen President Joan Claybrook. The administration has also used such language in recently proposed automobile safety rules.
"This is a sneak attack on consumer rights," Claybrook said. "President Bush is once again abusing his executive powers, this time in his attempt to protect the big pharmaceutical companies from the consequences of their actions. Thousands of people in this country have died or been seriously injured by drugs approved by the FDA, and this administration is saying it doesn’t think people should have any recourse."
It remains unclear what impact the language will have on liability cases.
"Ultimately, we are confident that the courts will not defer to the FDA’s opinion on preemption, which is not based on any authority given to the FDA by Congress," said Brian Wolfman, director of the Public Citizen Litigation Group and an expert on preemption law. "In the meantime, however, the drug companies will be emboldened by this preemption statement, and use it to complicate injury cases and deter victims from seeking justice in the courts."
Drug labeling has been a problem for decades.
In 1981, the Reagan administration cancelled a proposed regulation requiring FDA-approved leaflets to be dispensed with prescriptions just before the rule was to go into effect. The abrupt reversal came at the behest of drug companies, pharmacy organizations and some physician groups. Private sector-designed leaflets, not approved by the FDA, thereby continued to be the norm.
Several years ago, shortly after Dr. Mark B. McClellan became FDA commissioner, he listed as one of his top five priorities helping consumers obtain truthful information about products they use so they can make informed decisions. The FDA could go a long way toward achieving this priority by immediately moving forward with a long-overdue initiative to require the mandatory distribution of FDA-approved written drug information with each new and refill prescription, Wolfe said.
In a study conducted several years ago by the University of Wisconsin for the FDA, although 89 percent of consumers were receiving some sort of information (unregulated PILs) when a prescription was filled, none of the approximately 1,300 leaflets studied for four common drugs achieved minimum goals for useful, scientifically accurate drug information. As measured by eight objective criteria, the overall usefulness of information was about 50 percent. According to the authors, "a majority of leaflets did not include adequate information about contraindications, precautions, and how to avoid harm."
"The notion that consumer drug information can be 50 percent useful is unfathomable," Wolfe said. "Drug information that communicates only half of what it should is misleading, and misleading drug information is potentially dangerous."
Provided by Public Citizen on 1/18/2006
Late last month a coalition of public health and community organizations took the U.S. Environmental Protection Agency (EPA) to court for failing to adopt lead-safe regulations for repairs and renovations in older housing, according to a lawsuit filed by Public Employees for Environmental Responsibility (PEER). Even though EPA’s own estimates concede that additional delay in issuing regulations annually exposes 1.4 million children to risk of lead poisoning, the lead-safe rules are still not in place more than nine years after the legal deadline.
"We cannot afford to wait any longer for EPA to shoulder its statutory obligations, especially when the health of our children is at stake," stated PEER General Counsel Richard Condit, who filed the suit. "Each year of inaction means that tens of thousands of American kids will be exposed to lead paint dust and suffer irreversible damage, such as lost IQ points and developmental disabilities."
According to EPA documents:
- Each year, approximately 7 million home renovations produce hazardous quantities of lead dust;
- Repeated studies show the relationship between these renovations and elevated blood lead levels in children. In Chicago, for example, one in five children under age 5 has dangerously elevated blood-lead levels; and
- Adoption of comprehensive renovation regulations would yield a net economic benefit of at least $2.73 billion per year, derived primarily from reduced illnesses and other negative health effects.
By law, EPA is supposed to require that certified contractors and workers trained in lead-safe practices perform all remodeling in buildings constructed before 1978. By law, EPA was required to have its "regulations to renovation or remodeling activities" in place by October 28, 1996. These repair and renovation regulations are considered the last major step towards meeting the national goal of eliminating childhood lead poisoning by 2010, according to a presidential task force report issued in 2000.
Under President Clinton, EPA’s anti-lead efforts were tardy but were fitfully proceeding. Under President George W. Bush, however, progress on lead-safe rules grounded to a complete halt. In 2004, EPA secretly ordered that the rules be abandoned altogether. In March 2005, PEER published internal agency documents exposing the secret order, as well as internal studies showing large net benefits from a strong rule. After some dissembling and under mounting congressional pressure, EPA has promised to finally go forward with rules sometime in 2006.
While grudgingly pledging to take action, the Bush Administration has hamstrung the proposed rules behind the scenes by imposing crippling cost restrictions and unreasonable assumptions, according to internal agency documents posted today by PEER. One such assumption is that industry will immediately invent a new, inexpensive swab that is 90% accurate in detecting lead paint.
"This lawsuit will hold the Bush administration’s feet to the fire and make sure that they follow the whole law, not just the easy parts," Condit added.
Joining PEER in filing suit are the Maine Lead Action Project, The Lead and Environmental Hazards Association ( Olney, MD), Improving Kids’ Environment ( Indianapolis), Project 504 ( Minneapolis), Group 14621 Community Association, Inc. ( Rochester), Organization of the New Eastside ( Indianapolis), and Lutheran Metropolitan Ministry ( Cleveland).
Lead poisoning is an insideous and quite devestating condition that is often simply undetected. Widespread exposure to lead contaminants is something eveyone needs to avoid. It does seem to me that a significant role ought to be played by the EPA in helping people stay safe from the environmental contamination described in the action by PEER.
You can access more details from the PEER site here.
It is always distressing having to deal with children in hospital emergency departments when they present seriously ill from totally preventable causes. An all-too-common example is poisoning after taking medicines they should never have been able to access.
According to a report released on January 12, 2006 by the Centers for Disease Control and Prevention (CDC) keeping medications out of the easy grasp of children four and younger in the home is a significant health issue in the United States. These young children are more likely to be hospitalized for unintentionally swallowing medications than other causes of unintentional injury.
From 2001-2003, an estimated 53,500 children four years and younger were treated in hospital emergency departments each year after swallowing medications not intended for them or given in error. Almost three-fourths of these children were one to two years old and 75 percent of the incidents occurred in the home.
The report also indicated that children four and younger who are treated for medication exposure in the emergency room are nearly four times more likely to be hospitalized or transferred to specialized care than for other unintentional injuries. This indicates the severity of the damage caused and the complexity of care required.
National estimates for this study were based upon data from 3,600 sample cases from U.S. hospitals. About 40 percent of the ingestions involved common over-the-counter drugs like acetaminophen, cold and cough medications, non-steroid anti-inflammatory medications, antihistamines, and vitamins.
Prescription drugs accounted for most of the remaining medication ingestions. The types of medications most commonly leading to hospitalization or transfer to specialized care were anti-seizure medications, calcium channel blockers, anti-depressants, and oral diabetes medications.
Although specific information about how these incidents occurred was available for only about 15 percent of the cases, in most of these cases medications were not properly stored in their original containers, according to Dr. Dan Budnitz, one of the CDC study authors.
"Emergency room reports often do not provide detailed information on the circumstances surrounding the incidents," said Budnitz, "But the information available suggests that it’s important to keep medications out of sight and reach of young children."
Unintentional incidents involving medication by young children can also result in death. While not part of this study, information from death certificates in 2002 indicated that 35 children ages four years and younger died of poisoning after swallowing medications. Also, over 550,000 incidents involving medications are reported each year for children under age six.
For these reasons parents and others who are responsible for supervising children should remain vigilant in protecting children from inadvertent access to medications. Here are several prevention recommendations from the CDC:
- When possible, keep the medicines in their original containers. If medicines are transferred to other containers, be extra vigilant to ensure children do not have access to them. If you store medicines in your purse or a pill box, make sure that children do not have access.
- Store all medications in secured cabinets and out of reach of children.
- Avoid taking medicines in front of children, because they tend to imitate adults.
- Do not call any medicine ‘candy’.
- Make sure your visitors do not leave their medicines where children can easily find them.
- Post the U.S. poison control number 1-800-222-1222 on or near every phone at home. Put it in your speed dial on your mobile phone.
For more information about poisoning prevention, visit the CDC Injury Center’s website at www.cdc.gov/injury.
In the U.S. the CDC also advises to discard all unused medicines by flushing down the toilet. This is a practice that will one day be regretted. Australia has a policy of encouraging people to take unwanted medicines to pharmacy outlets, called chemists or pharmacies in Australia and drug stores in north America. This is a far better solution.
I have not seen evidence but credible hearsay suggests that domestic water supplies in the U.K. now have measurable quantities of several drugs in them, including Prozac! Simply flushing medicines down the toilet puts enormous quantities of drugs into the environment, since eventually sewage waste is either recycled or dumped where it does find its way into various ecosystems. Sewage treatment doesn’t remove these drugs, nor does water treatment, which is to be expected since they were never designed to.
Add to this the problem that some people will confuse sewage outlets for stormwater drainage systems and the problem quickly grows worse. Check with your drug store or local hospital to see if they will take medicines from you for safer disposal. Frankly, I never want to be taking someone else’s disposed medication! Do you?
I may be quick to condemn the FDA for its impotence in protecting consumers from pharmaceuticals and medical equipment and for failing to remove clearly dangerous chemicals such as aspartame from foods and medicines but I am always happy to acknowledge when the FDA does act wisely and helps to ensure consumer safety and wellbeing. This is one of those occasions when I acknowledge a very positive move by the FDA.
Effective January 1, 2006, the Food and Drug Administration (FDA) is requiring food labels to clearly state if food products contain any ingredients that contain protein derived from the eight major allergenic foods. As a result of the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA), manufacturers are required to identify in plain English the presence of ingredients that contain protein derived from milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, or soybeans in the list of ingredients or to say "contains" followed by name of the source of the food allergen after or adjacent to the list of ingredients.
The FDA says this labeling will be especially helpful to children who must learn to recognize the presence of substances they must avoid. In fact, it will be helpful to everyone for that very reason. For example, if a product contains the milk-derived protein, casein, the product’s label will have to use the term "milk" in addition to the term "casein" so that those with milk allergies can clearly understand the presence of the allergen they need to avoid.
It is estimated that 2 percent of adults and about 5 percent of infants and young children in the United States suffer from true food allergies. Approximately 30,000 consumers require emergency room treatment and 150 Americans die each year because of allergic reactions to food.
Food allergies are immune system reactions to specific food molecules. True allergies involve production of a type of antibody called immunoglobulin E (IgE). These usually develop quickly after consuming an allergen containing food which helps in the identification of the offending food. These allergies are the ones that sometimes cause sudden life-threatening reactions and deaths. Some true food allergies are quite mild, such as a brief, itchy rash. However, repeated exposure to the allergen can result in sugnificant and sudden worsening of the reactions so people need to avoid known food allergens.
Many more people suffer from food sensitivities. These involve triggering an IgG rather than IgE response. These reactions tend to be milder and more delayed. The delay can make it difficult to isolate the source of the reaction. Food sensitivities, being milder and where the cause is difficult to identify and avoid, tend to give rise to chronic inflammatory conditions such as the allergic triad (hay fever, asthma and eczema), inflammatory bowel disease and rheumatic disorders including arthritis.
"The eight major food allergens account for 90 percent of all documented food allergic reactions, and some reactions may be severe or life-threatening," said Robert E. Brackett, PhD, Director of FDA’s Center for Food Safety and Applied Nutrition. "Consumers will benefit from improved food labels for products that contain food allergens."
FALCPA does not require food manufacturers or retailers to relabel or remove from grocery or supermarket shelves products that do not reflect the additional allergen labeling as long as the products were labeled before the effective date. As a result, FDA cautions consumers that there will be a transition period of undetermined length during which it is likely that consumers will see packaged food on store shelves and in consumers’ homes without the revised allergen labeling.
For more information about FALCPA, visit FDA’s food allergy page at http://www.cfsan.fda.gov/~dms/wh-alrgy.html.
If you suspect you may have food allergies or sensitivities consult a naturopathic doctor. If it turns out you do have problems with certain foods these new labeling laws will be of great benefit in your efforts to eliminate offending food products from your diet.
The Centers for Disease Control and Prevention (CDC) announced today that clinicians should not prescribe two common antivirals (amantadine and rimantadine) to treat or prevent influenza during the 2005-2006 influenza season. Laboratory testing by CDC on the predominant strain of influenza (H3N2) currently circulating in the United States shows that it is resistant to these drugs.
CDC has tested 120 influenza A (H3N2) virus isolates and found that 109 (or 91 percent) were resistant to amantadine and rimantadine. This represents a sharp increase from last year when only 11 percent of isolates tested were resistant and 1.9 percent were resistant the year before that. However, all H3 and H1 influenza viruses tested to date are susceptible to the other commonly used antivirals (oseltamivir and zanamivir). This is certainly convenient, given the government’s massive purchase of oseltamivir (Tamiflu).
"This is certainly unexpected news as we now have to remove a few tools from our tool box that we use to combat influenza," said CDC Director Dr. Julie Gerberding. "Thankfully we still have antivirals available that work but this new development serves as a reminder of the importance of getting people vaccinated to prevent them from getting influenza in the first place." During this period CDC recommends oseltamivir (Tamiflu) and zanamivir (Relenza) be prescribed if an antiviral medication is needed for the treatment or prevention of influenza.
Of course there are other ways of preventing infection and ways of speeding recovery but CDC seems to have no interest in those. That’s not really surprising of course, for two main reasons. First, they have huge stockpiles they need to sell — oh yes, this is about marketing, they have to sell this stuff. Second, very powerful politicans have financial interests in the pharmaceutical company that makes Tamiflu.
Influenza activity is starting to pick up across the country as eighteen states are reporting either widespread or regional activity. This year over 80 million doses of vaccine have been distributed but remaining supplies vary from state to state. Also, CDC will have available 3.5 million doses from its stockpile to sell through manufacturers as soon as possible. In addition there are doses of vaccine presently available for sale by manufacturers and distributors.
Testing of influenza isolates for resistance to antivirals will continue throughout the 2005-2006 influenza season and recommendations will be updated as needed. In addition, CDC is working with state and local health departments and clinicians across the country to monitor drug resistance in influenza viruses.
For more information please visit www.cdc.gov/flu. Go there, that is, if you are happy to suspend critical thinking skills and remain of the uninformed view that CDC, as a government agency, is completely scientifically objective and totally above reproach.
The fact is there is no such thing as truely objective science. Health science, so closely associated with powerful motivation and huge sums of money, is especially caught up in politico-economic forces and vulnerable to distortion and corruption.
I think it is very telling that Dr Gerberding of the CDC acknowledged with the following response to a question, that the CDC, with all-the-kings-horses-and-all-the-king’s-men level of scientific resources, cannot account for the sudden, unexpected and extreme loss of efficacy in the drugs being abandoned.
"We don’t know exactly why resistance has risen so much to these drugs this year, and that’s something that we’ll have to do more investigation to determine. The hypothesis that a mutation accounted for this is just a hypothesis right now. Certainly the mechanism of resistance is a change in an amino acid associated with the activity of the drug, but we will have to do a great deal more science before we have clearly understood why, and why now, and why so much."
When Dr Gerberding was asked how long the two drugs being abandoned have been around, she said, "I can’t give you a quick answer on how old they are, but they’re off patent and they’ve been around long enough to be past the point where they’re non-generic, so we have a lot of experience with both of the drugs. Rimantadine is a bit younger than amantadine. I don’t know if you have any specific information … We can get back to you with the history."
Yes, "off patent". So, being somewhat decoded, the people of power and money can no longer make enough profit from these drugs. Fortunately, CDC scientists can be brought in to rescue the situation by declaring — quite suddenly, even to the point of calling the press conference on a weekend — that the old drugs don’t seem to work. They can’t account for it but the evidence is dramatic and persuasive they announce. Fortunately, Tamiflu, the drug that was purchased in massive quantities (Rumsfeld’s money, also see the politics of Rumsfeld here) under the guize of the so-called bird-flu scare, but for which it is next to useless, can now be consumed.
You can find a transcript of the CDC press conference at the following link. It makes very interesting reading if you know enough background to be able to read between the lines. http://www.cdc.gov/od/oc/media/transcripts/t060114.htm. My earlier stand on flu vaccination is found via this link: Is flu vaccination necessary?